Implantable, Multiprogrammable Pacemaker Pulse-Generator

No FDA recalls on record, checked 22 Oct 2026.

Full name

Implantable, Multiprogrammable

510(k) Number

K820774 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K833098 Active Cleared 19 Oct 1983

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• Pulse Generator

  Class III

  FDA 510(k) K821073 Active Cleared 7 May 1982

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  FDA 510(k) K863480 Active Cleared 23 Sep 1986

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• What clinical conditions is this implantable pacemaker designed to treat, and how does its programmability benefit patients?

  This device is specifically designed to treat bradycardia and other conduction disorders requiring chronic pacing support. Its programmability allows clinicians to adjust pacing parameters—such as heart rate, timing, and output—post-implantation to tailor therapy to each patient’s evolving needs, improving long-term efficacy and comfort.

• Is this pacemaker intended for reuse after implantation, or is it meant to be used only once?

  The device is supplied sterile and intended for single-use implantation, meaning it is not designed for reuse. However, its multiprogrammable features enable post-implantation adjustments to pacing parameters, allowing for ongoing clinical optimization without replacing the device itself.

• How many model variants exist for this pacemaker, and are there any differences between them?

  This device includes multiple model variants, each identified by unique FEI numbers (e.g., 3002807576, 2017865, etc.). While the exact specifications of each variant are not detailed here, the differences likely relate to technical parameters like battery life, pacing algorithms, or lead compatibility. For precise model comparisons, refer to Biotronik’s technical documentation or consult a clinical specialist.

• What regulatory pathway was followed for FDA clearance, and how does this affect its use in clinical practice?

  This device received FDA 510(k) clearance (K820774) under the Traditional review pathway, with a decision of *Substantially Equivalent* to a predicate device. This means it meets FDA standards for safety and effectiveness as an Implantable Pacemaker Pulse-Generator (product code DXY) and is authorized for use in patients with bradycardia or conduction disorders requiring chronic pacing. The clearance does not imply MRI compatibility or reusable components.

• How should this device be stored before implantation, and are there any special handling requirements?

  As a sterile, single-use implantable device, it should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging is designed to maintain sterility until use, so avoid opening or handling the device until immediately before implantation. Always follow Biotronik’s specific storage instructions provided in the accompanying documentation.